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Surgical Site Infection in Soft Tissue Sarcoma Patients with 24-hour Prophylactic Antibiotic Courses versus Antibiotic Administration Until Drainage Removal: A Randomized, Double-Blinded, Non-Inferiority Trial

Surgical Site Infection in Soft Tissue Sarcoma Patients with 24-hour Prophylactic Antibiotic Courses versus Antibiotic Administration Until Drainage Removal: A Randomized, Double-Blinded, Non-Inferiority Trial

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20240718002
Enrollment
144
Registered
2024-07-18
Start date
2021-06-17
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical site infection (SSI) is a frequent complication following resection of soft tissue sarcoma (STS), with an incidence of 8-14%. Using prophylactic antibiotics decreases SSIs. However, there is ongoing debate regarding the optimal duration of prophylactic antibiotics. Antibiotics, Soft tissue sarcoma, Orthopedic oncology, Randomized controlled trial, Statistical analysis plan

Interventions

Cefazolin 2 grams intravenous every 8 hours for 24 hours, then NSS intravenous every 8 hours until remove suction drain,Cefazolin 2 grams intravenous every 8 hours until remove suction drain
Experimental Drug,Active Comparator Drug
Postoperative antibiotic prophylaxis 24-hour, Postoperative antibiotic prophylaxis until remove suction drain

Sponsors

Department Orthopaedic Surgery
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age 18 years old or older 2. Provisional diagnosis as soft tissue sarcoma 3. Plan for soft tissue sarcoma resection at musculoskeletal area 4. Plan for drain insertion after surgery

Exclusion criteria

Exclusion criteria: 1. Penicillin allergy 2. Previous culture reported that microbes cannot be treated by cephalosporins 3. Previous antibiotic use within 7 days before surgery 4. Previous infection at surgical site 5. Chronic kidney disease (creatinine clearance less than 10 ml/min), required hemodialysis or kidney transplant 6. History of chemotherapy less than 3 weeks 7. Immunocompromised patient 8. Pathological report shown no soft tissue sarcoma

Design outcomes

Primary

MeasureTime frame
Surgical site infection rate 2, 4 weeks Percentage of surgical site infection rate

Secondary

MeasureTime frame
Medical complications (i.e. nosocomial infection, pressure ulcer, heart failure) 2, 4 weeks Count the point

Countries

Thailand

Contacts

Public ContactApichat Asavamongkolkul

Siriraj Hospital

apichat.asa@mahidol.ac.th024197968

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026